Loravis 50 microgram/ml eye drops, solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Latanoprost

Tilgjengelig fra:

Zaklady Farmaceutyczne POLPHARMA S.A.

ATC-kode:

S01EE01

INN (International Name):

Latanoprost

Legemiddelform:

Eye drops, solution

Terapeutisk område:

latanoprost

Autorisasjon dato:

2022-01-07

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LORAVIS 50 MICROGRAM/ML EYE DROPS, SOLUTION
latanoprost
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you or for your child only. Do
not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Loravis is and what it is used for
2.
What you need to know before you use Loravis
3.
How to use Loravis
4.
Possible side effects
5.
How to store Loravis
6.
Contents of the pack and other information
1.
WHAT LORAVIS IS AND WHAT IT IS USED FOR
Loravis contains latanoprost and it belongs to a group of medicines
known as prostaglandin analogues.
It lowers the pressure within your eye by increasing the natural
outflow of fluid from inside the eye
into the blood stream.
Loravis is used to treat a type of glaucoma called
OPEN ANGLE GLAUCOMA
and also a condition known as
OCULAR HYPERTENSION
in adults. Both of these conditions are linked with an increase in the
pressure
within your eye and eventually they may affect your eyesight.
Loravis is also used to treat increased eye pressure and glaucoma in
all ages of children and babies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LORAVIS
Loravis can be used in adult men and women (including the elderly) and
in children from birth to 18
years of age. Loravis has not been investigated in prematurely born
infants (less than 36 weeks
gestation).
DO NOT USE LORAVIS

if you are
ALLERGIC
to latanoprost or any of the other ingredients of this medicine
(listed in
section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor, or the doctor treating your child
or pharmacist before using Loravis:

if you or your

Preparatomtale

Health Products Regulatory Authority
23 October 2023
CRN00DRSP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Loravis 50 microgram/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms of latanoprost.
Each drop contains approximately 1.5 micrograms of latanoprost.
Excipient(s) with known effect:
Each ml of eye drops, solution contains 6.4 mg (0.2 mg per drop) of
phosphates (as disodium phosphate and sodium
dihydrogen phosphate monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution (Eye drops)
The solution is a clear, colourless liquid.
pH is in the range of 5.5 to 6.5
Osmolality is in the range of 250 to 320 mOsmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open angle
glaucoma and ocular hypertension.
Reduction of elevated intraocular pressure in paediatric patients with
elevated intraocular pressure and paediatric glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended dosage for adults (including the elderly)_
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is obtained if latanoprost is
administered in the evening.
The dosage of latanoprost should not exceed once daily since it has
been shown that more frequent administration decreases
the intraocular pressure lowering effect.
If one dose is missed, treatment should continue with the next dose as
normal.
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachrymal sac be compressed at the
medial canthus (punctal occlusion) for one minute. This should be
performed immediately following the instillation of each
drop.
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after 15 minutes.
If more than one topical ophthalmic medicinal products is being used,
the medicinal products should be administered at least
five minutes apar